Overview

A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

Status:
Completed
Trial end date:
2020-01-09
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kowa Research Institute, Inc.
Criteria
Inclusion Criteria:

- Be at least 18 years of age at the time of informed consent visit.

- Have a reported history of dry eye disease in both eyes and a history of eye drop use
for dry eye symptoms.

- Meet all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

- Have any clinically significant ocular condition.

- Have a history of corneal refractive surgery and/or any other ocular surgical
procedure within 12 months.

- Must not meet any other exclusion criteria outlined in the clinical study protocol.